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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SOFTWARE KIT 9733652 FUSION ENT - EU-SW
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491793 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT - EU-NW
MEDTRONIC NAVIGATION, INC.
9733652
Not in Commercial Distribution

  • 00643169491786 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652 FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491779 ()


  • ENT stereotactic surgery system
SOFTWARE KIT 9733652XOM FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169491762 ()


  • ENT stereotactic surgery system
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Leica Biosystems CytoVision Tissue FISH Software
Leica Biosystems Richmond, Inc.
23SWRTFHXXX001
Not in Commercial Distribution

  • 00849832004400 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002FLX001
Not in Commercial Distribution

  • 00849832004394 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision FISH Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001FLX001
Not in Commercial Distribution

  • 00849832004387 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Z-stack software license
Leica Biosystems Richmond, Inc.
23SWR000ZSX001
In Commercial Distribution

  • 00849832004370 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision MFISH Software License
Leica Biosystems Richmond, Inc.
23SWR000MFX001
Not in Commercial Distribution

  • 00849832004363 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Update
Leica Biosystems Richmond, Inc.
23SWR002KLX001
Not in Commercial Distribution

  • 00849832003793 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Spot Counting Software
Leica Biosystems Richmond, Inc.
23SWRSPOTXX001
Not in Commercial Distribution

  • 00849832003724 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001KLX001
Not in Commercial Distribution

  • 00849832003670 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
SOFTWARE MMT-7335 V3.0 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
Not in Commercial Distribution

  • 00613994910639 ()


  • Patient health record information system application software
SOFTWARE MMT-7335 V1.3 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
In Commercial Distribution

  • 00613994605443 ()


  • Patient health record information system application software
SOFTWARE MMT-7335 V1.3 CARELINK PRO EN
MEDTRONIC MINIMED, INC.
MMT-7335
In Commercial Distribution

  • 00613994651938 ()


  • Patient health record information system application software
SOFTWARE 9734332 INSTALL TOOLS 3D FLUORO
MEDTRONIC NAVIGATION, INC.
9734332
In Commercial Distribution

  • 00613994878007 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9734733 S7 3D FLUORO CALIBRATN
MEDTRONIC NAVIGATION, INC.
9734733
In Commercial Distribution

  • 00613994844149 ()


  • Multi-purpose stereotactic surgery system
Medical computer loaded with Quadsense software.
EVENTUM ORTHOPAEDICS LTD
PC001
In Commercial Distribution

  • 05065012584516 ()


  • Arthroplasty force sensor display unit
Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution

  • 05060508820031 ()


  • Blood bank information system application software
2 PCS MER3400 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
MER3400
In Commercial Distribution

  • 05415067037121 ()
MER3400

  • Implantable cardiac device management application software
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
Somte Recording System Compumedics, no Software
COMPUMEDICS LIMITED
Somte
In Commercial Distribution

  • 09342451001733 ()
9012-0003-01

  • Polysomnograph
Somte PSG v2 System, No software
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001368 ()
9023-0002-01

  • Polysomnograph
Grael EEG v2 System - no software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001252 ()
9028-0003-02

  • Electroencephalograph
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
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